FDA recall D-1037-2017

Precision Dose Inc. · Class II · drug

Product

Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.

Reason for recall

Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.

Distribution

OH and CT

Key facts

Status
Terminated
Initiation date
2017-07-05
Report date
2017-08-09
Termination date
2018-03-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
South Beloit, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1037-2017